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Sildenafil citrate composition tablet as medicine for treating urological diseases

A technology of sildenafil citrate and urology, applied in the field of medicine, can solve the problems of large influence on drug stability, difficult preparation of preparations, etc. Effect

Inactive Publication Date: 2015-09-30
QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Sildenafil citrate has strong hygroscopicity, and it is easy to absorb moisture and deteriorate under normal conditions. Therefore, the water content has a great influence on the stability of the drug. It is necessary to strictly control the product quality, which brings great difficulties to the preparation of the preparation.

Method used

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  • Sildenafil citrate composition tablet as medicine for treating urological diseases
  • Sildenafil citrate composition tablet as medicine for treating urological diseases
  • Sildenafil citrate composition tablet as medicine for treating urological diseases

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1: the preparation of sildenafil citrate crystal

[0028] (1) Add the solid sildenafil citrate to a mixed solvent of 2,4-lutidine and ether at 45°C, the volume of the mixed solvent is 10 times the weight of sildenafil citrate, 2, The volume ratio of 4-lutidine to ether is 5:1.5;

[0029] (2) Under the condition of controlling the temperature at 45°C, add a mixed solvent of ethanol and methyl salicylate to the solution obtained in step (1), the volume of the mixed solvent is 12 times the weight of sildenafil citrate, The volume ratio of ethanol and methyl salicylate is 3:1;

[0030] (3) After adding the mixed solvent of ethanol and methyl salicylate, cool down to -10-°C at a rate of 6.5°C / min, and stand at -10-°C for 5 hours to precipitate crystals, filter, wash, and vacuum dry The sildenafil citrate compound is obtained.

[0031] The prepared sildenafil citrate crystal uses Cu-Kα ray to measure the X-ray powder diffraction pattern obtained as figure 1 sho...

Embodiment 2

[0032] Embodiment 2: the preparation of sildenafil citrate composition tablet:

[0033] Prescription: in parts by weight as shown in Table 1

[0034] Table 1 Prescription of sildenafil citrate composition

[0035]

[0036] (1) Processing of raw and auxiliary materials: Sodium carbonate, dextrin, sucrose, and sildenafil citrate are passed through a 100-mesh sieve with a vibrating sieve;

[0037] (2) Weighing: Weigh each raw and auxiliary material according to the prescription amount;

[0038] (3) Preparation of adhesive: Dissolve the prescribed amount of povidone K30 in purified water to make an aqueous solution of povidone k30;

[0039] (4) Granulation: add internally added raw and auxiliary materials sildenafil citrate, sodium carbonate, starch, dextrin, sucrose, and crospovidone into the high-speed mixing granulator, and turn on the stirring motor at low speed (I speed) Mix for 10 minutes, add povidone K30 aqueous solution, wet mix at low speed (I speed) for 90-120 sec...

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PUM

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Abstract

The invention discloses a sildenafil citrate composition tablet as a medicine for treating urological diseases. The tablet is prepared from internally-added raw auxiliary materials, a binder and externally-added auxiliary materials, wherein the internally-added raw auxiliary materials comprise sildenafil citrate, sodium carbonate, starch, dextrin, cane sugar and crospovidone; the binder is prepared from povidone K30 and purified water; the externally-added auxiliary materials comprises carboxymethyl starch sodium and magnesium stearate. According to the invention, the sildenafil citrate is a compound with a new crystal form, X-ray powder diffraction pattern, measured by using a Cu-K alpha ray, of the sildenafil citrate is shown in the graph 1 (in the description), and the sildenafil citrate provided by the invention is different from the sildenafil citrate reported in the prior art; experiment results prove that the compound with the new crystal structure has improved hygroscopicity; compared with the prior art, the tablet prepared from the sildenafil citrate compound with the new crystal form has the advantages that the dissolution rate is high, the stability is good, the water content and impurity content are low, and the safety of clinical application is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a sildenafil citrate composition tablet for treating urological diseases. Background technique [0002] Sildenafil is an effective drug for the treatment of erectile dysfunction caused by objective and subjective reasons. It was approved by the FDA as a prescription drug in the United States in March 1997. Sildenafil is a highly selective phosphodiesterase 5 (PDE5 ) inhibitor, PDE5 is highly expressed in the corpus cavernosum, while its expression is low in other tissues (including platelets, blood vessels, visceral smooth muscle, and skeletal muscle). Sildenafil selectively inhibits PDE5, enhances the nitric oxide (NO)-cGMP pathway, and increases the level of cGMP to cause the relaxation of the smooth muscle of the cavernous body of the penis, so that patients with erectile dysfunction can produce a natural erectile response to sexual stimulation. Erectile response generally inc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/519C07D487/04A61P13/00A61P15/10
Inventor 王玉美
Owner QINGDAO LANSHENGYANG PHARMA & BIOTECH CO LTD
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